The latest market report published by Credence Research, Inc. “Oncology Biosimilars Market – Growth, Future Prospects, Competitive Analysis, 2018 – 2026,” the global oncology biosimilars market was valued at US$ 1,651.5 Mn in 2017 expanding at a CAGR of 28.3% from 2018 to 2026.
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Market Insights
According to the U.S. Food and Drug Administration (FDA), biosimilar is a biological product that is highly similar to an existing, approved reference product and has no clinically meaningful differences. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.
The number of biosimilar approvals soared in the United States as five of nine approved biosimilars across different disease conditions received U.S. FDA approval. Furthermore, U.S. witnessed the approvals of oncology biosimilars such as Amgen’s Mvasi (bevacizumab-awwb), a biosimilar to Genentech’s Avastin for the treatment of lung, colorectal, kidney, brain and cervical cancers; and Mylan’s Ogivri (trastuzumab-dkst), a biosimilar to Herceptin for treating breast cancer, gastric cancer, and gastrointestinal cancer.
The USFDA is determined to increase biosimilar approvals, especially for cancer as cancer treatment imposes a high cost burden on patients. Although the prices of oncology biosimilars are less compared to biologics, the savings are not on the same scale as compared to generics and patented non-biological drugs. Savings of 20% – 30% compared to the reference biologic product have been observed in major markets such as Europe and North America, making biosimilars as a lucrative alternative.
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In terms of drug class, the granulocyte colony-stimulating factor (G-CSF) held the largest share in the oncology biosimilars market owing to its early approvals in Europe and U.S. However, monoclonal antibodies class expected to grow at a highest growth rate and emerge as the largest market in 2026 due to recent approvals of Mvasi (bevacizumab-awwb) and Ogivri (trastuzumab-dkst) in the United States.
Moreover, robust pipeline and patent expiration of major biologics during the forecast period would further assist the market growth of monoclonal antibodies. In terms of disease condition, neutropenia led the market due to approvals of filgrastim and Peg-filgrastim to multiple pharmaceutical companies in Europe and Asia Pacific.
However, breast cancer is projected to proliferate at a humungous rate due to high prevalence of breast cancer globally and recent approval of trastuzumab in Europe and North America.
Europe dominated the global oncology biosimilars market in 2017 due to presence of approved oncology biosimilar such as filgrastim, trastuzumab and rituximab in the region. Moreover, the European Medicines Agency (EMA) have put forth guidelines for the approval of biosimilars through regulatory bodies such as European Society of Medical Oncology (ESMO). North America is anticipated to exhibit rapid growth in oncology biosimilars market due to market entry of breakthrough oncology biosimilars and vigorous pipeline expected to hit the market during the forecast period.
The prominent players actively engaged in the oncology biosimilars market are Samsung Bioepis, Celltrion Inc., Biocon, Dr. Reddy’s Laboratories Ltd., Intas Pharmaceuticals Ltd., STADA Arzneimittel AG, Pfizer Inc., Sandoz Inc., Teva Pharmaceutical Industries Ltd., Apotex Inc., and BIOCAD. Robust pipeline and ongoing clinical trials in U.S. and Europe are driving the oncology biosimilars market. For instance, Pfizer has six biosimilars in phase III of clinical trials, testing for drugs such as Rituxan/MabThera, Herceptin, Avastin and Humira.
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